30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.

Key facts

Study ID

NCT01183013

Run by

Boehringer Ingelheim

People needed

936

Starts

2010-08-01

Expected to finish

2013-02-01

Last updated by the study team

2014-10-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 2 diabetes mellitus prior to informed consent
• Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
• Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
• BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
• Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation

You may not qualify if…

• Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
• Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
• Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
• Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
• Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
• Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)
• Contraindications to pioglitazone as defined in the local prescribing information (SPC), particularly :
• Diagnose of heart failure or history of heart failure
• Haemodialysis patients, due to limited experience with pioglitazone
• Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
• Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
• Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
• Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
• Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
• Participation in another trial with an investigational drug within 30 days prior to informed consent
• Any other clinical condition as judged by the investigator that would not allow the safe completion of the protocol, e.g. inability of patients to comply with study procedures
• Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:
• are nursing or pregnant or
• are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
• A highly effective method of birth control is defined - according to the Note for Guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) - as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices/systems (IUDs/IUSs), sexual abstinence or vasectomised partner
• Symptomatic gallbladder disease in the last six months
• Medical history of pancreatitis.
• Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
• Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.

Where it is running

• 1264.3.01021 Boehringer Ingelheim Investigational Site — Montgomery, Alabama, United States
• 1264.3.01020 Boehringer Ingelheim Investigational Site — Muscle Shoals, Alabama, United States
• 1264.3.01062 Boehringer Ingelheim Investigational Site — Chandler, Arizona, United States
• 1264.3.01064 Boehringer Ingelheim Investigational Site — Mesa, Arizona, United States
• 1264.3.01049 Boehringer Ingelheim Investigational Site — Carmichael, California, United States
• 1264.3.01078 Boehringer Ingelheim Investigational Site — Chino, California, United States
• 1264.3.01031 Boehringer Ingelheim Investigational Site — Concord, California, United States
• 1264.3.01037 Boehringer Ingelheim Investigational Site — Lakewood, California, United States
• 1264.3.01065 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1264.3.01006 Boehringer Ingelheim Investigational Site — Norwalk, California, United States
• 1264.3.01001 Boehringer Ingelheim Investigational Site — Rancho Cucamonga, California, United States
• 1264.3.01059 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1264.3.01023 Boehringer Ingelheim Investigational Site — Tarzana, California, United States
• 1264.3.01016 Boehringer Ingelheim Investigational Site — Tustin, California, United States
• 1264.3.01058 Boehringer Ingelheim Investigational Site — Valencia, California, United States
• 1264.3.01083 Boehringer Ingelheim Investigational Site — Westlake Village, California, United States
• 1264.3.01027 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 1264.3.01033 Boehringer Ingelheim Investigational Site — Norwalk, Connecticut, United States
• 1264.3.01035 Boehringer Ingelheim Investigational Site — Boca Raton, Florida, United States
• 1264.3.01015 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1264.3.01082 Boehringer Ingelheim Investigational Site — Hialeah, Florida, United States
• 1264.3.01036 Boehringer Ingelheim Investigational Site — Jacksonville, Florida, United States
• 1264.3.01013 Boehringer Ingelheim Investigational Site — Longwood, Florida, United States
• 1264.3.01038 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1264.3.01026 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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